资源描述：
《恩曲它滨质量标准》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。
1、Monographs:Pharmaceuticalsubstances:Emtricitabinum・EmtricitabineHONH2FC8H2FN3O3SRelativemolecularmass・247.2Chemicalname・Samino-S-fluoro-l-ia/^SSAZYhydroxymethylAlQ-oxathiolarvS-yllpyrimidirHZd^O-one;5-fluoro-l-[(2Hz5S)-2-(hydroxymethyl)-l/3-oxathiolan-
2、5-yl]cytosine;(-)-2,/3,-dideoxy-5-fluoro-3,-thiacytidine;CASReg.N°143491-57-0.Description.Whitetoalmostwhite,crystallinepowder.Solubility.FreelysolubleinmethanolRandwaterRzpracticallyinsolubleindichloromethaneR.Category・Antiretroviral(NucleosideReverse
3、TranscriptaseInhibitor)・Storage.Emtricitabineshouldbekeptinatightlyclosedcontainer.Additionalinformation.Emtricitabinemayexhibitpolymorphism・RequirementsDefinition.Emtricitabinecontainsnotlessthan99.0%andnotmorethan101.0%ofemtricitabine(C8H10FN3O3S)，ca
4、lculatedwithreferencetothedriedsubstanee.Manufacture・Theproductionmethodisvalidatedtoensurethatthesubstanee,iftested,wouldcomplywithalimitofnotmorethan0.3%forthe(2S,5R)・enantiomerusingasuitablechiralchromatographicmethod・Identitytests•EithertestsArBand
5、DortestsCandDmaybeapplied.A.CarryouttestA・1o匚whereUVdetectionisnotavailable,testA・2・A・1Carryoutthetestasdescribedunder1.14.1ThinJaverchromatograDhv,usingsilicagelR6asthecoatingsubstaneeandamixtureof90volumesofdichloromethane10volumesofmethanolRand3volu
6、mesofglacialaceticacidRasthemobilephase・Applyseparatelytotheplate5plofthefollowingtwosolutionsinmethanolR・Forsolution(A)use5mgofthetestsubstaneeperml.Forsolution(B)use5mgofemtricitabineRSperml.Afterremovingtheplatefromthechromatographicchamber,allowitt
7、odryexhaustivelyinairorinacurrentofcoolair.Examinethechromatograminultravioletlight(254nm)・TheprincipalspotobtainedwithsolutionAcorrespondsinposition,appearanee,andintensitywiiththatobtainedwithsolutionB・A.2Carryoutthetestasdescriedunder1.14.1,Thin-lay
8、erchromatograDhv,usingtheconditionsdescribedundertestA.lbutusingsilicagelR5asthecoatingsubstanee.Staintheplatewithiodinevaporandexamiineindaylight・TheprincipalspotobtainedwithsolutionAcorrespondsinposition,appearanee,andintensitywiithth
